BRISBANE, Calif., May 8 /PRNewswire-FirstCall/ -- InterMune, Inc. announced results today from preclinical studies of pirfenidone that identify a molecular target of the compound's anti-fibrotic activity. Pirfenidone is the Company's small molecule drug candidate that is being developed for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in its Phase III program, CAPACITY. The in vitro studies demonstrate that pirfenidone suppresses fibrogenesis through selective inhibition of the p38-gamma mitogen-activated protein kinase (MAPK). The results will be included in a presentation made today by InterMune scientists at GTCbio's Protein Kinases in Drug Discovery and Development Conference being held in Boston, Massachusetts.
In IPF, fibrosis occurs when wound healing cells deposit collagen, which leads to abnormal scarring of the lung tissues. Previous research demonstrates that pirfenidone reduces blood plasma levels in vivo of TGF-beta and Interleukin-4, two pro-fibrotic signaling molecules, and significantly inhibits TGF-beta-induced collagen synthesis in vitro. Pirfenidone was also shown to inhibit production of TNF-alpha, a molecule involved with inflammation. In this new work, InterMune scientists have shown a principal anti-fibrotic mechanism of action of pirfenidone as the inhibition of the p38- gamma kinase. In support of this, InterMune studies have demonstrated specificity of pirfenidone for the p38-gamma isoforms in biochemical kinase assays as well as the attenuation of TGF-beta induced collagen synthesis following treatment of cells with pirfenidone. These new studies demonstrate a link between inhibition of p38-gamma and a specific marker of fibrogenesis.
"Extensive industry-wide research has demonstrated that the p38-alpha isoform regulates numerous biological processes that play an important role in inflammatory diseases. The anti-fibrotic mechanism of action of pirfenidone involving selective inhibition of p38-gamma and its associated inhibition of collagen synthesis may prove to be an important element in the treatment of fibrotic lung diseases. InterMune's ongoing CAPACITY trials are designed to ascertain if the anti-fibrotic activity of pirfenidone will result in significant benefit for patients with IPF," said Lawrence M. Blatt, Ph.D., Chief Scientific Officer of InterMune.
About IPF
IPF is a disabling and ultimately fatal disease that affects approximately 83,000 people in the United States, with approximately 30,000 new cases developing each year. InterMune estimates there is a significant IPF population in Europe. Those diagnosed with IPF are usually between the ages of 40 and 70, and the disease tends to affect men more than women. IPF causes inflammation and scarring (fibrosis) in the lungs, hindering a person's ability to process oxygen and causing shortness of breath (dyspnea) and cough. IPF is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity. The disease is very deadly, with a median survival time from diagnosis of two to five years, and a five-year survival rate of approximately 20 percent. There are currently no drugs approved by the U.S. Food and Drug Administration (FDA) and European Medicines Evaluation Agency (EMEA) for the treatment of IPF.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes two Phase III programs evaluating possible therapeutic candidates for treatment of patients with IPF: the INSPIRE trial is evaluating Actimmune(R) and the CAPACITY program is evaluating pirfenidone. The hepatology portfolio includes the lead HCV protease inhibitor compound, ITMN-191, formerly referred to as ITMN B, a second-generation HCV protease inhibitor program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to the progress, future patient enrollment in and timing of our clinical trials and announcements of results thereof. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's annual report on Form 10-K filed with the SEC on March 13, 2006 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) risks related to the development of our product and product candidates; (ii) risks related to timely patient enrollment and retention in clinical trials, including the use of third parties to conduct such clinical trials; (iii) risks related to achieving positive clinical trial results; (iv) risks related to our intellectual property rights; and (v) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC.
InterMune, Inc.CONTACT: investors, Investor Relations Dept of InterMune, Inc.,+1-415-466-2242, or ir@intermune.com; or media, Pam Lord of Porter NovelliLife Sciences, +1-858-527-3494, or plord@pnlifesciences.com, for InterMune,Inc.
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